Label: 5% MINOXIDIL TOPICAL SOLUTION- minoxidil solution
- NDC Code(s): 49539-001-01
- Packager: AVACOR PRODUCTS, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated April 1, 2019
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
DO NOT USE
- you are a woman
- your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp, 5% minoxidil topical solution is not intended for frontal baldness or receding hairline
- you have no family history of hair loss
- your hair loss is sudden and/or patchy
- you do not know the reason for your hair loss
- you are under 18 years of age. Do not use on babies and children
- your scalp is red, inflamed, irritated or painful • you use other medicines on the scalp
- ASK DOCTOR
• do not apply on other parts of the body • avoid contact with the eyes. In case of accidental contact, rinse eyes with
large amounts of cool tap water • some people have experienced changes in hair color and/or texture
• it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to
use this product for at least 4 months before you see results. • the amount of hair regrowth is different for each person.
This product will not work for all men.
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INSTRUCTIONS FOR USE
OTHER SAFETY INFORMATION
• see hair loss pictures on side of this carton
• before use, read all information on carton and enclosed leaflet
• keep the carton, It contains important information.
• hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men.
• in clinical studies of mostly white men age 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution.
• store at USP controlled room temperature 20º to 25ºC (68º to 77ºF).
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
5% MINOXIDIL TOPICAL SOLUTION
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49539-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 5 g in 100 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49539-001-01 3 in 1 CARTON 04/01/2019 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076239 04/01/2019 Labeler - AVACOR PRODUCTS, LLC (080364950) Registrant - AVACOR PRODUCTS, LLC (080364950)